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Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

Primary Purpose

Colonic Polyp

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Visual estimation of polyp size
Napoleon measurement of polyp size
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colonic Polyp

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients:

Inclusion Criteria:

  1. Adult age 45 and above
  2. Undergoing a colonoscopy performed by a gastroenterology fellow
  3. Willingness and ability to provide informed consent

Exclusion Criteria:

  1. History of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement)
  2. Undergoing a diagnostic colonoscopy for inflammatory bowel disease or other known inflammatory/infectious process

An individual who meets any of the following criteria during the colonoscopy will be excluded from participation in this study:

  1. Colonoscopy without polyps
  2. Polyps not removed in entirety
  3. Polyps with indeterminate size

An individual who meets any of the following criteria after the colonoscopy will be excluded from participation in this study:

1. Hyperplastic or non-adenomatous polyps on pathology report

Fellows

Inclusion Criteria:

  1. NYU gastroenterology fellow
  2. Willingness and ability to provide informed consent

Exclusion Criteria:

1. Not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending

Sites / Locations

  • NYU Langone Hospital BrooklynRecruiting
  • Bellevue Hospital CenterRecruiting
  • Manhattan VA Medical CenterRecruiting
  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Colonoscopy Patients + their Gastroenterology Fellows

Arm Description

Inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from October 2020 - March 2021. These will include all colonoscopies with polyps done in adults age 45 and above.

Outcomes

Primary Outcome Measures

Difference in polyp measurement between visual assessment and using Napoleon in fellows
Difference in accuracy of polyp measurement among fellow years
Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon
Difference in polyp measurement between histology and using Napoleon
Proportion of cases with a difference in the recommended surveillance interval based on polyp size

Secondary Outcome Measures

Full Information

First Posted
April 20, 2021
Last Updated
April 10, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04858477
Brief Title
Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
Official Title
Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a clinical trial assessing gastroenterology fellows' accuracy of colonic polyp measurement using a Micro-Tech Endoscopic Polyp Measurement Device named Napoleon. The study will evaluate the feasibility of Napoleon as a polyp measurement device. Investigators will collect data on inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from May 2021 - May 2022 for 150 patients. Investigators will include all colonoscopies with polyps done in adults age 45 and above. For each colonoscopy, a fellow will first visually estimate the polyp size and then measure the polyp with Napoleon. Investigators will calculate the difference in polyp measurement between visual assessment and using Napoleon for each fellow year and compare differences among fellow years. Investigators will evaluate for changes in fellows' accuracy of polyp measurement with subsequent uses of Napoleon. Investigators will determine the proportion of cases with a change in the recommended surveillance interval based on polyp size. A survey will be given to all fellows to assess the level of ease with using Napoleon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colonoscopy Patients + their Gastroenterology Fellows
Arm Type
Other
Arm Description
Inpatient and outpatient colonoscopies performed by fellows at NYU Langone Health, NYU Langone Hospital Brooklyn, Bellevue Hospital Center, and Manhattan VA Medical Center from October 2020 - March 2021. These will include all colonoscopies with polyps done in adults age 45 and above.
Intervention Type
Other
Intervention Name(s)
Visual estimation of polyp size
Intervention Description
For each colonoscopy, a fellow will first visually estimate the polyp size
Intervention Type
Other
Intervention Name(s)
Napoleon measurement of polyp size
Intervention Description
For each colonoscopy, a fellow will first visually estimate the polyp size and then measure the polyp with Napoleon. The Micro-Tech Endoscopic Polyp Measurement Device named Napoleon is a small catheter with a 15mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA.
Primary Outcome Measure Information:
Title
Difference in polyp measurement between visual assessment and using Napoleon in fellows
Time Frame
6 months
Title
Difference in accuracy of polyp measurement among fellow years
Time Frame
6 months
Title
Difference in fellows' accuracy of polyp measurement with subsequent uses of Napoleon
Time Frame
6 months
Title
Difference in polyp measurement between histology and using Napoleon
Time Frame
6 months
Title
Proportion of cases with a difference in the recommended surveillance interval based on polyp size
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients: Inclusion Criteria: Adult age 45 and above Undergoing a colonoscopy performed by a gastroenterology fellow Willingness and ability to provide informed consent Exclusion Criteria: History of not tolerating prior colonoscopies well or difficult colonoscopies (e.g. high sedative requirement) Undergoing a diagnostic colonoscopy for inflammatory bowel disease or other known inflammatory/infectious process An individual who meets any of the following criteria during the colonoscopy will be excluded from participation in this study: Colonoscopy without polyps Polyps not removed in entirety Polyps with indeterminate size An individual who meets any of the following criteria after the colonoscopy will be excluded from participation in this study: 1. Hyperplastic or non-adenomatous polyps on pathology report Fellows Inclusion Criteria: NYU gastroenterology fellow Willingness and ability to provide informed consent Exclusion Criteria: 1. Not deemed to be medically trained and ready to perform a colonoscopy by supervising gastroenterology attending
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renee Williams, MD
Phone
646-501-4116
Email
Renee.Williams@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sandy Ng, MD
Email
Sandy.Ng@nyulangone.org
Facility Information:
Facility Name
NYU Langone Hospital Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Goodman, MD
Facility Name
Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Williams, MD
Facility Name
Manhattan VA Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violeta Popov, MD
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Williams, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Renee.Williams@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
IPD Sharing Access Criteria
Requests may be directed to: Renee.Williams@nyulangone.org

Learn more about this trial

Use of the Napoleon to Improve Polyp Measurement in Gastroenterology Fellows

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